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Reporting Standardization in

Pathology
Elizabeth H Hammond MD FCAP
Topics To Cover
Why standardize reporting?
Cancer Care Ontario
LDS Hospital cancer report changes
HER2 reporting challenges
Why Standardize Reporting?
Reports are the tangible product of our
pathology work
To be useful, reports must provide
„ Clear, consistent information
„ All elements necessary for decision making
„ Information about validity of process
„ Format allowing for easy retrieval and
searching
Pathology Product is Information
Quality of information defines our
competence to others
„ More than our training
„ More than our experience
„ More than our colleague interactions
Reports document our services
„ For protection against malpractice risk
„ For billing purposes
„ To document “pay for performance” that CMS will
implement
Elements of Good Reports
Includes critical values and how
information was communicated.
Easy for the reader to find information
Minimum standards for required
information met for each report
Disclaimers when required
Documentation for billing
Documentation of consultations
Appropriate formatting of
amendments/addenda for clarity
Cancer Care Ontario
Full continuum of cancer care
„ Prevention, screening, diagnosis, treatment,
supportive care, palliation
Population $11 million +
158 hospitals, 43 community care access
centres, 37 public health units and 18 district
health councils
50,000+ incident cancer cases per year
Focus on making better use of ~ $2 Billion
currently being spent on cancer care
Pilot Study: Breast Cancer
692 of total 1,921(36%) breast cancer
pathology reports;
All labs submitting electronically
Convenience sample; all reports for smaller
volume centres and at least 25 for larger
volume labs
May 1 - July 31, 2004
Detailed analysis of selected CAP checklist
elements
30 Institutions – All Elements
Breast Cancer Pathology Reports, May-July 2004*, Ontario. N=692

Breast Case volume vs completeness (%


completeness ranked in order)
250 100%

essential elements
200 80%
3 month case

% with all
volume

150 60%
100 40%
50 20%
0 0%

Source: Cancer Care Ontario/Ontario Cancer Registry Special Study 2004. * Convenience sample.
Not for distribution.
Breast Pathologic Reporting
Breast pathologic reporting
Completion of required elements vs format of presentation
Sample of all Ontario hospitals
100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

0%
overall Non synoptic format synoptic format
Series1 53% 27% 63%
Summary
Completeness is reasonable across the
province
Synoptic format improved completeness
levels
There are significant regional variations
The interpretation of what cases to apply the
full checklist to for breast cancer is variable
across the province and has implications for
analysis
LDS Hospital
550 bed hospital in Salt Lake City
Provides 60% of cancer care for state
Flag ship adult hospital for Intermountain
Healthcare, a large non profit integrated
delivery system in Utah
„ 60% of hospital beds in state
„ 1.2 million of 2 million population covered by
health plan
„ Long history of use of computerized health records
and associated quality assurance initiatives
Reporting Change at LDS Hospital
Determined that cancer reports resulted in
many disruptive phone calls
Reviewed extent of problem for breast cancer
reports
Flow charted process and did cause and
effect analysis
Consulted with clinicians about critical report
elements
Implemented synoptic reporting to correct
the problem after teaching discussion
Evaluated the effect on our practice
PHONE CALL FREQUENCY BY SURVEY
GROUP

35.00%

30.00%

25.00%
% OF REPORTS

20.00%

15.00%

10.00%

5.00%

0.00%
ONCOLOGISTS TUMOR
1
SECRETARIES
2 3
REGISTRY
Recommendations of NQF

Design work so that


it is easy to do it right
and hard to do it wrong.

THE NATIONAL FORUM


FOR HEALTH CARE
QUALITY MEASUREMENT
AND REPORTING
We Implemented Synoptic Reporting
Format In An Iterative Fashion
• A teaching discussion with pathologists defined
how to fill in the required fields in the new report.

• A draft synoptic report was tested for acceptance


by pathologists for one month.

• A followup conference was held to modify the


form based on suggestions of oncologists and
pathologists.

• The form was put in place.


Holding the Gain
1990 1993 1995
Total number of reports 356 250 190
Total # complete reports 299 242 188
Total # incomplete reports 32 8 1
# missing gross info 10 8 1
# missing micro info 22 0 0
Total # confusing info 25 0 0
Practice Implications

Decreased phone calls about cancer reports


Satisfied clinicians….we even get fan mail!
Simplified transcription with lessened
workload; elimination of ~1 FTE
Less pathologist interruption
Less pathologist resistance
More consistent reporting
More oncologist satisfaction
Oncologist Satisfaction (1996)*

100% (16/16) reported they were


satisfied with the report format
100% (16/16) indicated the report was
clear and complete
94% (15/16) wanted
estrogen/progesterone receptor added
* Survey was sent to 31 oncologists. 16 of the 31 (52%)
responded. 100% of the medical and radiation
oncologists responded.
Followup
Checklists from CAP were adapted to our
clinicians.
CAP Checklists are approved as ACOS
accreditation requirements for cancer hospitals
Synoptic formats (checklists) implemented as
WORD macros with a pick list of choices for each
element to standardize data for retrieval.
WORD macros interfaced with AP computer
system and all pathologists trained in use.
Macros modified by clinician or pathologist
suggestion to Informatics Committee
Information transmitted through HL7 interface to
data warehouse for cancer management
Example of IHC Breast Macro Data Entry Screen
IHC Breast Nottingham Score Grading Elements

Tubule Formation
Majority of tumor > 75% (score = 1)
Moderate 10% to 75% (score = 2)
Minimal < 10% (score = 3)

Nuclear Pleomorphism
Small regular nuclei (score = 1)
Moderate increase in size, etc. (score = 2)
Marked increase in size, nucleoli, chromatin clumping, etc. (score = 3)

Mitotic Count 25x Objective


10 mitoses per 10 HPF (score = 1)
10-20 mitoses per 10 HPF (score = 2)
20 mitoses per 10 HPF (score = 3)

Total Score
Grade I: 3-5 points
Grade II: 6-7 points
Grade III: 8-9 points
IHC Breast Macro Data Elements

Extent Of Invasion
TX: Cannot be assessed
T0: No evidence of primary tumor
Tis: Carcinoma in-situ: Intraductal carcinoma, lobular carcinoma in-
situ, or aget's disease of the nipple with no tumor
T1: Tumor < 2 cm. in greatest dimension
T1mic: Microinvasion < 0.1 cm. in greatest dimension
T1a: > 0.1 cm. but < 0.5 cm. in greatest dimension
T1b: > 0.5 cm. but < 1 cm. in greatest dimension
T1c: > 1 cm. but < 2 cm. in greatest dimension
T2: Tumor > 2 cm. but < 5 cm. in greatest dimension
T3: Tumor > 5 cm. in greatest dimension
T4: Tumor of any size with direct extension to chest wall or skin
T4a: Tumor of any size with direct extension to chest wall
T4b: Tumor of any size with edema (including peau d'orange) or
ulceration of the skin of the breast or satellite skin nodules confined
to the same breast
T4c: Both T4a and T4b
T4d: Inflammatory carcinoma
Breast Preservation Rate
Data Source: CR & Casemix

Breast Conservation Rate for Stages 0-2b Adjusted for Age/Stage: all
1.0

0.9

0.8 (varies)

0.7

0.6 0.62
Proportion

0.5
(varies)
0.4

0.3

0.2

0.1

0.0
1Q 1Q 1Q 1Q 1Q 1Q
2Q 3Q 4Q 2Q 3Q 4Q 2Q 3Q 4Q 2Q 3Q 4Q 2Q 3Q 4Q 2Q 3Q 4Q
2001 2002 2003 2004 2005 2006

0.48 0.60 0.53


42 169
Proportion 0.56 0.49 0.57 0.54 0.55 0.65 0.55 0.69 0.64 0.64 0.72 0.66 0.65 0.67 0.69 0.63 0.67 0.63 0.67 0.60 0.76
n
Cases: 3170 164 141 144 145 142 133 148 154 137 143 146 147 154 136 151 134 113 123 118 120 99 67

Target is 60%
N=3170, 2000-2006
HER2 Testing Standardization

Surveys of pathologists have shown considerable


variation in HER2 reporting practices
NCCN and ASCO-CAP have produced consensus
guidelines to improve HER2 testing in 2006
Both guidelines enumerate checklist reporting
elements which are easily adapted to checklist report
formats to improve clarity and avoid missing
information.
New guidelines and resultant education should
change this.
Reporting for HER2 in 1998*
50% of labs report the HER2 test method that
they used.
75% report the degree of overexpression
when they report IHC test results.
20% report test as positive or negative
without other information

*Genentech survey. N=110


Reporting Template
Requirements
Standardize report format and language so
oncologists and patients understand all
important information:
„ Sample identification (block/slide/case)
„ Method used (specifics of test/vendor)
„ Controls used (positive and negative)
„ Assay result and reference ranges
„ If secondary testing will be done, describe how
and when it will be reported
„ Provide a comment that describes the laboratory
qualifications as an adjunct to the report (optional
but desirable)
Summary
Synoptic reporting is advantageous for all
types of reports
„ Avoid confusion and error
„ Provide clarity and consistency
„ Provide all necessary information for clinical
decision making
„ Promotes faster, safer communication about
patient results
Effective changes in reporting require
clinician-pathologist consensus
Implementation has ancillary benefits to
systems and regulators